药品名称ESTRADERM
申请号019081产品号002
活性成分ESTRADIOL市场状态处方药
剂型或给药途径FILM, EXTENDED RELEASE;TRANSDERMAL规格0.05MG/24HR
治疗等效代码BX参比药物
批准日期1986/09/10申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New dosage form审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
019081042APLetter2012/07/09下载
019081042APLabel2012/07/13下载
019081040APLetter2004/12/30下载
019081040APLabel2004/12/30下载
019081039APLabel2004/06/01下载
019081039APLetter2004/06/01下载
019081039APReview2008/08/01下载
019081036APLabel2004/06/01下载
019081036APLetter2004/06/01下载
019081036APReview2008/08/01下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
019081042AP2012/07/03Labeling Revision
019081040AP2004/12/17Labeling Revision
019081039AP2004/05/28Labeling Revision
019081036AP2004/05/28Labeling Revision
019081035AP2002/03/14Manufacturing Change or Addition
019081034AP2001/08/20Manufacturing Change or Addition
019081031AP1997/12/10Labeling Revision
019081029AP1996/06/27Control Supplement
019081028AP1996/06/27Control Supplement
019081027AP1995/12/07Labeling Revision
019081026AP1995/11/28Labeling Revision
019081025AP1995/01/20Manufacturing Change or Addition
019081024AP1995/02/10Formulation Revision
019081023AP1994/05/18Formulation Revision
019081022AP1993/04/05Labeling Revision
019081021AP1993/08/09Control Supplement
019081020AP1995/09/22Labeling Revision
019081019AP1992/01/22Control Supplement
019081018AP1991/10/24New or Modified Indication
019081017AP1990/06/12Manufacturing Change or Addition
019081015AP1990/06/19Labeling Revision
019081014AP1990/06/18Control Supplement
019081013AP1990/01/19Formulation Revision
019081011AP1989/02/03Manufacturing Change or Addition
019081010AP1988/07/01Control Supplement
019081009AP1988/05/25Package Change
019081008AP1988/04/28Labeling Revision
019081007AP1987/07/07Labeling Revision
019081006AP1988/01/07Manufacturing Change or Addition
019081005AP1988/01/07Manufacturing Change or Addition
019081004AP1988/01/07Manufacturing Change or Addition
019081003AP1988/01/07Manufacturing Change or Addition
019081002AP1987/02/26Labeling Revision
019081001AP1986/12/03Control Supplement
019081000AP1986/09/10Approval